The mission of the Clinical Trials Support Resource is to serve the patients, faculty, and staff of The University of Texas M. D. Anderson Cancer Center by facilitating the approval and performance of clinical research of the highest quality in an ethical and cost-effective fashion. The Clinical Trials Support Resource is supported by the staff of the Office of Research Administration directed by the Vice President for Research Administration. The 4 specialized areas that support the resource are: Protocol Approval and Regulatory Affairs, Protocol Research Quality Assurance, Research Administration Information Systems, and Research Finance. Close to 40 full-time equivalent positions provide some level of support to this resource. The Protocol Approval Group provides services related to the central management and oversight of clinical trials conducted at the institution. They also manage the centralized database for protocol specific data and keep the priority lists of current active protocols. The Regulatory Affairs staff also provides the administrative support required to run M. D. Anderson's Data Monitoring Committee. The Quality Assurance Group provides education to faculty, fellows, research nurses and data managers on Good Clinical Practice and the federal, state and institutional regulations that related to the conduct of human subjects research. During the last year, this group has implemented a formal rigorous training program required for all new research nurses entering the institution. (A similar program for faculty began in September, 2002) The training course, which is also open to other employees, takes approximately 20% of the individual's time for the first month of employment. The quality assurance group also provides resources to investigators for data auditing using the Protocol Data Management Systems (PDMS), the investigators' clinical files and the participants' medical records. The Information Systems Group is responsible for the development and maintenance of all databases used to store clinical trials data and to manage protocols. They have written all the code that allows electronic transmission of protocol data to the NCI, Theradex and industry sponsors. They are currently in the process of developing a web based Oracle system of data entry for use by research nurses, data managers and principal investigators. The new system, called CORe (Clinical Oncology Research), will replace the outdated data entry features of PDMS but retain all the functionalities. CORe is being developed in modules and to date the modules that have been released for use include patient registration and eligibility, adverse events and off study reports. The module to enable investigators to prepare for the continuing review of protocols is currently being developed. The Research Finance Group provides investigators with support in preparing budgets to determine the cost of conducting clinical trials prior to protocol approval. This will enable investigators to ensure that sufficient funds are available to conduct the study prior to enrolling patients and allows an informed negotiation process with outside sponsors. There are currently 278 cancer center members who utilize this facility of which 37% hold peer reviewed funding. During the last five years, the number of new clinical protocols managed annually has increased 233%. Users of the PDMS have increased 50% and transfers of data have tripled.